Why clinical research in England takes twice as long as it should, and what is actually causing the delay

Why clinical research in England takes twice as long as it should, and what is actually causing the delay

Clinical research in England takes an average of more than 300 days from protocol approval to first patient recruited. Lord O'Shaughnessy's 2023 review called this unsustainable, and the broader picture reinforces why: the number of industry clinical trials initiated in the UK fell by 41% between 2017 and 2021, with cancer trials falling by the same margin (ABPI, 2022). A country with one of the strongest research infrastructures in the world is losing ground. The question is not whether the system is slow. The question is where the time actually goes.

The delay begins before the first patient is approached

Most conversations about slow studies focus on patient recruitment. Enrolment is visible, measurable and tied to milestone payments, so it attracts attention. But a significant portion of UK trial delays occur before recruitment begins. The bottleneck sits in site initiation: the period between regulatory approval and a site being operationally ready to enrol its first participant.

The O'Shaughnessy review identified this phase as a consistent problem. Sites that should activate in weeks routinely take months. Official government KPI data published in June 2026 shows that only 33% of commercial contract studies opened to recruitment within 60 days of regulatory approval, against a government target of 90% (DHSC, 2026). The causes are not dramatic failures. They are accumulated friction: documents submitted in the wrong format, ethics committee questions that go unanswered because they arrived in an overloaded inbox, sign-offs that require chasing across multiple organisations in sequence, version histories that live in someone's e-mail archive rather than a shared system.

Where the structural pressure points lie

The O'Shaughnessy review and ABPI analyses point consistently to the same pressure points across the UK research pathway:

• Wide variation in NHS Trust set-up timelines, even for studies with near-identical protocols, driven by differences in how individual Trusts resource and prioritise research activity.
• Contract and budget negotiations between sponsors, CROs and sites that proceed sequentially rather than in parallel, adding weeks to the pre-activation period.
• Approval and document processes that depend on e-mail chains and personal drives, making it difficult to track status, maintain version control, or reconstruct a clean audit trail.
• Research nurses and coordinators carrying a heavy administrative load, which reduces the time available for the clinical and patient-facing work that actually moves studies forward.

Post-Brexit, there is an additional layer: multinational studies that previously ran under a single EU regulatory pathway now require separate MHRA submissions, creating extra coordination steps for sponsors working across markets.

What organisations that perform better have in common

The organisations that have reduced start-up times most consistently share one pattern. They have moved away from managing research processes through e-mail and spreadsheets, and toward centralised systems where the status of every submission, document and approval is visible in real time to everyone who needs it.

Most trial delay is not caused by slow decisions. It is caused by slow discovery that a decision is needed. An approval about to lapse, a document awaiting a countersignature, a site that has stalled while others have progressed: none of these are visible in a fragmented system until someone goes looking. In a structured system, they surface automatically.

What this means for the UK

The O'Shaughnessy review set a target of under 200 days from regulatory application to first patient visit, a benchmark drawn from comparable systems in the USA, Spain and Australia. Reaching it does not require rebuilding the infrastructure the UK already has. It requires removing the operational friction between approval and activation, at every site, for every study.

That friction is not inevitable. Across European research environments, organisations that have moved their trial processes onto a single connected platform, where submission status, document versions and approval deadlines are visible in real time, have cut activation times significantly. The pathway stays the same. The fragmentation disappears.

At ResearchManager, we have spent 13 years helping research organisations work through exactly this. We are now exploring the UK market and are keen to understand how these challenges play out within the NHS. Our smart software tools help research teams reduce administrative friction across the full trial pathway. If shortening the pathway is on your agenda, we welcome the conversation.

Reach Hans at hans@myresearchmanager.com or visit our website.

References

Association of the British Pharmaceutical Industry. (2022). Rescuing patient access to industry clinical trials in the UK. ABPI. https://www.abpi.org.uk/publications/rescuing-the-uk-industry-clinical-trials/

Department of Health and Social Care. (2026). UK clinical research delivery key performance indicators: data to May 2026. GOV.UK. https://www.gov.uk/government/statistics/uk-clinical-research-delivery-key-performance-indicators-data-to-may-2026/uk-clinical-research-delivery-key-performance-indicators-data-to-may-2026

O'Shaughnessy, J. (2023). Independent review of commercial clinical trials in the UK: Final report. Department of Health and Social Care. https://www.gov.uk/government/publications/independent-review-of-commercial-clinical-trials-in-the-uk